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Clinical Innovations, LLC recalls The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or re
Recalled October 21, 2015 · FDA recall Z-0123-2016 · Clinical Innovations
Hazard
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed. · FDA Class II
Units
827 units
Sold at
Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
Description
Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
Product
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
Manufacturer(s)
Clinical Innovations, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →